Senior Consultant (EDC - Vault)
At 1,900 employees and growing and consistently strong financials (NYSE:VEEV), Veeva was named among the top fastest growing public technology companies on Forbes’ annual Fast Tech 25 list. We build innovative cloud solutions for some of the world’s largest pharmas and biotechs, and we need great people like you to make it happen.
Our Culture & People
Our core values are Employee Success, Customer Success, and Speed. We are innovators, collaborators, and thought leaders out to create best-in-class solutions that help our customers improve and extend human life. It’s genuine, straight-forward, and no fuss.
Tired of working with old EDC technology? Looking for an opportunity to change how clinical trials, data and data are managed? Veeva’s Vault Electronic Data Capture (EDC) application will truly change how the industry runs clinical trials and we want you on our team!
Veeva Systems is looking for Senior Consultants who have deep design, configuration, data management, and clinical trial expertise with a passion for helping customers transform the way they manage their clinical trial data and content with Vault EDC.
As a key member of our EDC Professional Services team, the Senior Consultant will be at the forefront of our mission and responsible for three main things:
- Understand our customers’ clinical trial and protocol requirements and implement a study design with the Vault EDC application adhering to Good Clinical Data Management Practices and Veeva standards to optimize value.
- Responsible for authoring all specification documents used by team members and configuring the study design during the development phase of the project.
- Train and mentor customers and clinical sites who are working with the Vault EDC application or are new to clinical trials.
Opportunities are available across the United States for this role. The work location is remote within the U.S. Qualified U.S. based candidates are encouraged to apply.
- Work with customers to review and understand clinical protocol requirements and prepare, review and finalize all project specifications applying industry and Veeva best practices
- Configure Veeva products during development
- Support developers and testers during the project lifecycle
- Support the requirements gathering and specification creation process for all study integrations
- Conduct on-site or remote user acceptance testing with the customer including coordination of all feedback, resolution of issues and acceptance of the study
- Create user acceptance testing scripts (if applicable)
- Support go live activities for the study to ensure a smooth transition of the study to the customer
- Review requirements as part of the change management process and update specifications and configurations as necessary with associated scoping activities
- Support services pre-sales activities including review of customer requirements and scoping
- Act as the customers trusted advisor to ensure that the study trial design is configured in such a way that it meets the customer's goals and offers the full benefits of Veeva’s EDC application
- Engage with the training group to plan study training and deliver internal external training as needed at investigator meetings and clinical sites (if applicable)
- Notify project management of project risks and develop contingency plans as necessary
- Ensure customer success from beginning to end of the project life cycle
- Assure process compliance with all regulatory and Veeva procedural requirements
- Participate and contribute to process, product, or best practices initiatives
- Adherence to all Veeva and EDC Services procedures and policies
- 5+ years’ direct experience working with EDC clinical software solutions in clinical operations, and/or trial management in a project management/consultant role
- Experience in interpreting clinical protocols and translating requirements into software specifications including writing and reviewing technical documentation
- Experience in a customer-facing role, preferably with a software professional services organization or consulting background is preferred
- Working Knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to design, document, and data collection
- Ability and willingness to “roll up your sleeves” to implement a clinical solution
- Ability to quickly understand business requirements
- Proven ability to work independently in a dynamic, fast-moving environment, but also as part of a team
- Logical approach to problem solving
- Ability to manage multiple tasks and project deliverables
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
- Demonstrated success with customers during project assessment, planning, development, training and implementation.
- Excellent verbal and written communication, interpersonal, and presentation skills
- Expert on life sciences compliance and computer systems validation requirements
- Ability to travel 25-30% (may include international)
- 4-year college degree required
- Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Life sciences industry experience and knowledge of clinical trial process preferred (pharmaceutical, biotech, medical device companies, CRO’s and academic & public health organizations).
- Direct experience with EDC systems such as Medidata RAVE or Oracle/Phase Forward InForm
- Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, and other clinical technologies
- Life Science, computer science or related degree
- Familiarity with CDISC, ODM and other data management industry standards
- JAVA experience and technical skills
- SaaS/Cloud experience in the delivery of clinical trials
- Enterprise experience and knowledge transfer for running clinical trials with EDC
- Experience with training for clinical sites and at investigator meetings
- Consulting experience
- Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
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